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D-0256-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0256-2015 was initiated by Baxter Healthcare Corp. on Nov 10, 2014 and is designated Class II. Reason for recall: Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL. The recall status is terminated (terminated Nov 3, 2016). Affected quantity: 63,360 container bags.

Recall Details

Product Type: Drugs
Report Date: Dec 3, 2014
Initiation Date: Nov 10, 2014
Termination Date: Nov 3, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 63,360 container bags

Product Description

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

Reason for Recall

Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Distribution Pattern

Nationwide

Code Information

Lot #: P319160, Exp 06/30/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0256-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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